Effectiveness and Safety of Rivaroxaban Versus Warfarin in Nonvalvular Atrial fibrillation Patients with a Non-Sex-Related CHA2DS2-VASc Score of 1.
Eur Heart J Cardiovasc Pharmacother. 2018 Jul 17;:
Authors: Coleman CI, Turpie AGG, Bunz TJ, Eriksson D, Sood NA, Baker WL
Aims: To compare the effectiveness and safety of standard dose rivaroxaban (20 mg once daily) and warfarin in nonvalvular atrial fibrillation (NVAF) patients with a non-sex-related CHA2DS2-VASc score of 1.
Methods and Results: Analysis of United States Truven MarketScan claims from 11/2011-12/2016 for anticoagulant-naïve NVAF patients with a single non-sex-related stroke risk factor assigned 1-point in the CHA2DS2-VASc score and ≥12-months of continuous medical/prescription insurance coverage prior to the qualifying oral anticoagulant dispensing. Standard dose rivaroxaban users were 1:1 propensity-matched to warfarin users. Patients were followed until outcome occurrence, insurance disenrollment or end of data availability. Primary outcomes included stroke or systemic embolism and major bleeding and were compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). 3,319 rivaroxaban users were 1:1 propensity-score matched to 3,319 warfarin users. Median (interquartile range) duration of follow-up was 1.6 (0.7, 2) years and the most common qualifying stroke risk factor was hypertension (n = 4532, 68.3%). Rivaroxaban was associated with a significant reduction in the 1-year stroke or systemic embolism versus warfarin (HR = 0.41, 95%CI=0.17-0.98), with no significant difference in overall major bleeding (HR = 0.74, 95%CI=0.44-1.26) or major bleeding subtypes (HR ranging from=0.33-0.78, p > 0.05 for all). Similar results were seen after extending follow-up to 2-years.
Conclusions: Rivaroxaban may lower the rate of stroke or systemic embolism versus warfarin in NVAF patients with a non-sex-related CHA2DS2-VASc score of 1 without impacting major bleeding.
PMID: 30020424 [PubMed – as supplied by publisher]